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The purpose of this study is to compare naproxen plasma levels and gastroduodenal mucosal injury after administration of LT-NS001 as compared to Naprosyn in subjects age 45-70.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LT-NS001 | Drug | 1200 mg b.i.d. p.o. for 7.5 days |
| |
| Naprosyn® |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of GI mucosal injury by endoscopy | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of naproxen PK at steady state | 7.5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20804454 | Derived | Goldstein JL, Jungwirthova A, David J, Spindel E, Bouchner L, Pesek F, Searle S, Skopek J, Grim J, Ulc I, Sewell KL. Clinical trial: endoscopic evaluation of naproxen etemesil, a naproxen prodrug, vs. naproxen - a proof-of-concept, randomized, double-blind, active-comparator study. Aliment Pharmacol Ther. 2010 Nov;32(9):1091-101. doi: 10.1111/j.1365-2036.2010.04442.x. Epub 2010 Aug 23. |
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| ID | Term |
|---|---|
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Drug |
500 mg b.i.d. p.o. for 7.5 days |
|
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |